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Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage III Non-small Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00334815
Enrollment
29
Registered
2006-06-08
Start date
2006-06-15
Completion date
2027-02-22
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Large Cell Carcinoma, Lung Squamous Cell Carcinoma, Minimally Invasive Lung Adenocarcinoma, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Brief summary

This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. Determine the frequency and severity of toxic effects of induction therapy comprising cisplatin, etoposide, and radiotherapy with or without bevacizumab followed by consolidation therapy comprising docetaxel and bevacizumab, in terms of grade 4 or 5 hemorrhage, in patients with newly diagnosed, unresectable, stage III non-small cell lung cancer. SECONDARY OBJECTIVES: I. Determine progression-free and overall survival of patients treated with these regimens. II. Determine response (confirmed, unconfirmed, partial, and complete) in patients with measurable disease treated with these regimens. OUTLINE: This is a pilot, multicenter study. Patients are stratified according to risk (high\* vs low). NOTE: \*High-risk stratum closed to accrual as of 2/20/09. INDUCTION THERAPY: Patients in each stratum are assigned to 1 of 3 sequential treatment groups. GROUP 1: Patients receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. GROUP 2: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57. GROUP 3: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43. CONSOLIDATION CHEMOTHERAPY: Beginning 3-6 weeks after completion of induction therapy, all patients receive consolidation chemotherapy comprising docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 2 and continuing until blood counts recover OR pegfilgrastim SC once on day 2. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 4 years.

Interventions

BIOLOGICALBevacizumab

Given IV

DRUGCisplatin

Given IV

DRUGDocetaxel

Given IV

DRUGEtoposide

Given IV

BIOLOGICALFilgrastim

Given SC

BIOLOGICALPegfilgrastim

Given SC

RADIATIONRadiation Therapy

Undergo thoracic radiotherapy

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologically or cytologically confirmed single, primary, bronchogenic, non-small cell lung cancer (NSCLC) * Newly diagnosed disease * Unresectable disease * No more than 1 parenchymal lesions on same or opposite sides of the lungs * Meets 1 of the following stage criteria: * Stage IIIA (N2) disease meeting the following criteria: * N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or x-ray so that the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection * N2 status must be documented by ≥ 1 of the following methods: * Histologically or cytologically confirmed N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle biopsy (WNB), fine needle aspiration (FNA) under bronchoscopic or CT guidance, or any other method * Node positive by fludeoxyglucose-positron emission tomography (FDG-PET) scan * Nodes \> 3 cm on CT scan * Paralyzed left true vocal cord with separate left lung primary distinct from anterior-posterior window nodes on CT scan * Stage IIIB disease meeting ≥ 1 of the following criteria: * Histologically or radiographically confirmed positive N3 nodes\*, documented by ≥ 1 of the following methods: * FNA, core needle biopsy (CNB), or excisional biopsy of supraclavicular N3 nodes * Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy * FNA, CNB, or WNB under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes * Contralateral mediastinal nodes \> 3 cm on CT scan * Node positivity by FDG-PET scan * Right-sided primary with paralyzed left true vocal cord * T4 lesions of any size that invade the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina, documented by ≥ 1 of the following methods: * Written documentation of type of T4 extent if patient had a prior exploratory thoracotomy or thoracoscopy * T4 involvement of the trachea or carina by direct bronchoscopic visualization * T4 involvement of the heart, esophagus, aorta, or vertebral body by CT scan, MRI, or transesophageal ultrasound * T4 involvement of the mediastinum by CT scan or MRI if, in the absence of the above organ involvement, there is soft tissue extension directly into the mediastinal space\*\* * Meets 1 of the following risk criteria: * Low risk disease, meeting the following criteria: * Non-squamous cell NSCLC, including adenocarcinoma, bronchoalveolar cell carcinoma, or large cell carcinoma * If mixed histology, the squamous cell carcinoma component must be \< 50% * Histology or cytology from involved mediastinal or supraclavicular lymph nodes allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., second biopsy not required) * No primary tumor with cavitation and/or tumor within 1 cm of a major vessel * No hemoptysis (i.e., bright red blood ≥ ½ teaspoon) in the past 28 days * High-risk\* disease, meeting ≥ 1 of the following criteria: * Squamous cell NSCLC * If mixed histology, the squamous cell component must be ≥ 50% * Tumor with any histology that has cavitation or is located within 1 cm of a major vessel * No aortic involvement * Any histology and hemoptysis (i.e., bright red blood ≥ ½ teaspoon) within past 28 days * Measurable or nonmeasurable disease by CT scan or MRI * Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease * No pleural effusion except for small pleural effusion visible on CT scan or MRI alone * No pericardial effusions * No metastatic disease involving the contralateral chest, liver, or adrenals confirmed by CT scan of the upper abdomen or by chest CT scan with complete liver and adrenals in the report * Patients must be offered participation in SWOG-S9925 (Lung Cancer Specimen Repository Protocol) * No brain metastases by CT scan or MRI * No evidence of cavitation * Creatinine normal * Creatinine clearance ≥ 50 mL/min * FEV\_1 ≥ 2.0 liters OR predicted FEV\_1 of the contralateral lung \> 800 mL * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Urine protein: creatinine ratio ≤ 0.5 by urinalysis OR urine protein \< 1,000 mg by 24-hour urine collection * INR \< 1.5 * Zubrod performance status 0-1 * No sensory neuropathy \> grade 1 * No cerebrovascular accident within the past 6 months * No myocardial infarction or unstable angina within the past 6 months * No uncontrolled hypertension * No New York Heart Association class II-IV congestive heart failure * No serious cardiac arrhythmia requiring medication * No clinically significant peripheral vascular disease * No evidence of bleeding diathesis or coagulopathy * No pathologic condition other than lung cancer that carries a high risk of bleeding * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * No serious, nonhealing wound, ulcer, or bone fracture * No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or other cancer for which the patient has been disease-free for 5 years * Not pregnant or nursing * No nursing during and for ≥ 6 months after the last dose of bevacizumab * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 6 months after the last dose of bevacizumab * Must have pre-treatment simulation demonstrating a V20 ≤ 35% with planned radiation dose of 6,480 cGy * No prior surgical resection * Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery allowed for diagnosing, staging, or determining potential resectability of lung tumor * No prior chemotherapy or radiotherapy for lung cancer * No prior radiotherapy to the neck or thorax * At least 4 weeks since prior thoracic or other major surgery (excluding mediastinoscopy) and recovered * More than 7 days since prior FNA, CNB, or mediastinoscopy * No other concurrent anticancer therapy, including chemotherapy, radiotherapy, or biologic agents * No other concurrent investigational drugs * No concurrent major surgical procedures * No concurrent full-dose anticoagulants (e.g., low-molecular weight and unfractionated heparin or warfarin) * Low-dose warfarin (i.e., 1 mg) is allowed to prevent clotting of an infusaport or central line * No concurrent brachytherapy, radiopharmaceuticals, high linear energy transfer radiation (i.e., fast neutrons), particle therapy (i.e., protons, carbon, or helium), and/or altered fractionation schemes * No concurrent intensity-modulated radiotherapy * No concurrent prophylactic contralateral hilar or supraclavicular lymph node radiotherapy

Design outcomes

Primary

MeasureTime frameDescription
Adverse EventsUp to one yearOnly adverse events that are possibly, probably or definitely related to study drug are reported.

Secondary

MeasureTime frameDescription
Progression-free SurvivalDisease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Overall SurvivalEvery week, up to 4 yearsFrom date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Response Rate (Confirmed or Unconfirmed Partial Response)Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registrationGreater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAntoinette J Wozniak

SWOG Cancer Research Network

Participant flow

Participants by arm

ArmCount
Low Risk Patient Stratum15
High Risk Patient Stratum11
Total26

Baseline characteristics

CharacteristicLow Risk Patient StratumTotalHigh Risk Patient Stratum
Age, Continuous54.5 years60.5 years63.4 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants24 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants3 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
14 Participants23 Participants9 Participants
Region of Enrollment
United States
15 participants26 participants11 participants
Sex: Female, Male
Female
9 Participants13 Participants4 Participants
Sex: Female, Male
Male
6 Participants13 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
other
Total, other adverse events
26 / 2617 / 21
serious
Total, serious adverse events
0 / 263 / 21

Outcome results

Primary

Adverse Events

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Time frame: Up to one year

Population: All eligible patients, both low-risk and high-risk strata combined, who received protocol therapy.

ArmMeasureGroupValue (NUMBER)
Concurrent Chemotherapy and RadiotherapyAdverse EventsInf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsHemorrhage, Respiratory tract NOS0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsInf (clin/microbio) w/Gr 3-4 neuts - UTI1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsCarbon monoxide diffusion capacity (DL(co))1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsInf (clin/microbio) w/Gr 3-4 neuts - Upper airway0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsDyspnea (shortness of breath)1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsInf w/normal ANC or Gr 1-2 neutrophils - Blood1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsCreatinine1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsInf w/normal ANC or Gr 1-2 neutrophils - Lung1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPain - Neck1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsLeukocytes (total WBC)6 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsFebrile neutropenia3 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsLymphopenia2 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsEsophagitis2 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsMuscle weakness, not d/t neuropathy - body/general1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPlatelets2 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsNausea2 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsGlucose, serum-high (hyperglycemia)1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsNeutrophils/granulocytes (ANC/AGC)10 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsHemorrhage, GI - Peritoneal cavity0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPain - Chest wall1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsDehydration1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPain - Chest/thorax NOS1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsHemorrhage, pulmonary/upper respiratory - Lung0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPain - Head/headache1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPneumonitis/pulmonary infiltrates1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPain - Joint0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsHypotension1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPain - Throat/pharynx/larynx1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsHemoglobin2 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsHypoxia0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPotassium, serum-low (hypokalemia)3 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsArthritis (non-septic)0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsPulmonary/Upper Respiratory-Other (Specify)0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsINR (of prothrombin time)1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsRash/desquamation1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsFEV(1)1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsRash: dermatitis associated w/radiation1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsInf (clin/microbio) w/Gr 3-4 neuts - Nose1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsSodium, serum-low (hyponatremia)1 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsCalcium, serum-low (hypocalcemia)0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsWeight loss0 Participants
Concurrent Chemotherapy and RadiotherapyAdverse EventsAcidosis (metabolic or respiratory)0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsWeight loss1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsDehydration0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsEsophagitis0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsFEV(1)0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsGlucose, serum-high (hyperglycemia)0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsHemoglobin2 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsHemorrhage, Respiratory tract NOS1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPain - Neck0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPlatelets0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsAcidosis (metabolic or respiratory)1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsArthritis (non-septic)1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsCalcium, serum-low (hypocalcemia)1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsCarbon monoxide diffusion capacity (DL(co))0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsCreatinine0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsDyspnea (shortness of breath)1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsFebrile neutropenia0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsHemorrhage, GI - Peritoneal cavity1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsHemorrhage, pulmonary/upper respiratory - Lung1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsHypotension0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsHypoxia1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsINR (of prothrombin time)0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsInf (clin/microbio) w/Gr 3-4 neuts - Nose0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsInf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsInf (clin/microbio) w/Gr 3-4 neuts - UTI0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsInf (clin/microbio) w/Gr 3-4 neuts - Upper airway1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsInf w/normal ANC or Gr 1-2 neutrophils - Blood0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsInf w/normal ANC or Gr 1-2 neutrophils - Lung0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsLeukocytes (total WBC)0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsLymphopenia3 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsMuscle weakness, not d/t neuropathy - body/general1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsNausea0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsNeutrophils/granulocytes (ANC/AGC)0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPain - Chest wall0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPain - Chest/thorax NOS0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPain - Head/headache0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPain - Joint1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPain - Throat/pharynx/larynx0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPneumonitis/pulmonary infiltrates2 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPotassium, serum-low (hypokalemia)1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsPulmonary/Upper Respiratory-Other (Specify)1 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsRash/desquamation0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsRash: dermatitis associated w/radiation0 Participants
Consolidation Therapy With Docetaxel and Bevacizumab.Adverse EventsSodium, serum-low (hyponatremia)0 Participants
Secondary

Overall Survival

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Time frame: Every week, up to 4 years

ArmMeasureValue (MEDIAN)
Concurrent Chemotherapy and RadiotherapyOverall Survival46 Months
Consolidation Therapy With Docetaxel and Bevacizumab.Overall Survival17 Months
Secondary

Progression-free Survival

From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

Time frame: Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.

ArmMeasureValue (MEDIAN)
Concurrent Chemotherapy and RadiotherapyProgression-free Survival38 Months
Consolidation Therapy With Docetaxel and Bevacizumab.Progression-free Survival15 Months
Secondary

Response Rate (Confirmed or Unconfirmed Partial Response)

Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.

Time frame: Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration

Population: Only patients with measurable disease at baseline were included in the analysis of response. Among 15 patients on the Low Risk stratum, 14 had measureable disease at baseline. Among 11 patients on the High Risk stratum, 10 had measureable disease at baseline.

ArmMeasureValue (NUMBER)
Concurrent Chemotherapy and RadiotherapyResponse Rate (Confirmed or Unconfirmed Partial Response)64 percentage of participants
Consolidation Therapy With Docetaxel and Bevacizumab.Response Rate (Confirmed or Unconfirmed Partial Response)70 percentage of participants

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026