Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma

Conditions

Colorectal Cancer

Keywords

HIPEC

Brief summary

The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.

Detailed description

The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma. The Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) is expected to be an effective treatment with minimal side effects, it has already provided clear benefits in terms of overall survival in patients with advanced cancer. This is an attractive option for the healthcare professionals who face daily to peritoneal recurrence after performing complex surgeries, however its application is difficult due to the cost and resources increase. This leads to the necessity of administering the treatment within a clinical trials and in order to obtain a significant power this clinical trials will be multicenter and it will be performed in several Oncological surgery Units highly specialised and with extensive experience in colorectal carcinoma.

Álvaro Arjona‐Sánchez, Esther Espinosa-Redondo, Alberto Gutiérrez‐Calvo, Juan José Segura‐Sampedro, Estíbalitz Pérez-Viejo et al. (82 authors)

JAMA Surgery2023-04-26101 citations

10.1001/jamasurg.2023.0662

Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial.

Bastiaenen VP, Klaver CEL, Kok NFM, de Wilt JHW, de Hingh IHJT, Aalbers AGJ, Boerma D, Bremers AJA, Burger JWA, van Duyn EB, Evers P, van Grevenstein WMU, Hemmer PHJ, Madsen EVE, Snaebjornsson P, Tuynman JB, Wiezer MJ, Dijkgraaf MGW, van der Bilt JDW, Tanis PJ.

2019-03-2121 citations

10.1186/s12885-019-5408-8

Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in resected high-risk colon cancer patients – study protocol for the PIPAC-OPC3 Trial. A prospective, controlled phase 2 Study

Martin Graversen, Sönke Detlefsen, Claus Wilki Fristrup, Per Pfeiffer, Michael Bau Mortensen

Pleura and Peritoneum2018-06-0125 citations

10.1515/pp-2018-0107

HIPECT4: multicentre, randomized clinical trial to evaluate safety and efficacy of Hyperthermic intra-peritoneal chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma.

Arjona-Sánchez A, Barrios P, Boldo-Roda E, Camps B, Carrasco-Campos J, Concepción Martín V, García-Fadrique A, Gutiérrez-Calvo A, Morales R, Ortega-Pérez G, Pérez-Viejo E, Prada-Villaverde A, Torres-Melero J, Vicente E, Villarejo-Campos P, Sánchez-Hidalgo JM, Casado-Adam A, García-Martin R, Medina M, Caro T, Villar C, Aranda E, Cano-Osuna MT, Díaz-López C, Torres-Tordera E, Briceño-Delgado FJ, Rufián-Peña S.

2018-02-1360 citations

10.1186/s12885-018-4096-0

Interventions

DRUGMITOMYCIN-C 30 mg

Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC with Mytomicin C for 60 minutes.

PROCEDUREProactive cytoreductive surgery

Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

1. Male and female patients between the ages of 18 and 75 years; 2. Adenocarcinoma of the colon, sigma and colon-sigma joint which represent cT4a/b in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual; 3. Lymph node involvement: N0, the presence of N1/2 according to the 7th edition of the AJCC is allowed, provided that they can be resectable; 4. Metastatic extent: M0; 5. Karnofsky index \>70 or Performance status ≤2; 6. Informed consent properly completed.

Exclusion criteria

1. Presence of metastases (M1), in case of liver or peritoneal metastases at the time of surgery, the patient will be excluded from the trial and treated according to their new stage. 2. Presence of unresectability criteria; 3. Urgent intervention due to obstruction or perforation if there is tumor removal, prior interventions will be accepted as referrals without primary tumor removal or drainage of collections prior to scheduled surgery. 4. Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance); 5. Coexistence of another malignant neoplastic disease (synchronous tumors of the colon and upper rectum are accepted as long as the stage is equal to or less than the treated tumor). 6. Severely altered liver, kidney and cardiovascular function; 7. Intolerance to treatment; 8. Administration of chemotherapy before the trial (use of neoadyuvance is discarded); 9. Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame	Description
Locoregional Control (LC)	3 years	Time elapsed from the surgical intervention clinical up to the date the patient is free of clinical and radiological locoregional recurrence

Secondary

Measure	Time frame	Description
Disease Free Survival	12 months and 36 months after surgery	Evaluate the effect of addition of HIPEC with Mitomycin C to cytoreductive surgery in 12 months and 3 years disease free survival rate (% DFS).
Evaluation of the morbidity and mortality related with the treatment	36 months after surgery	Evaluate the safety (treatment-related morbidity and mortality) of addition of HIPEC with Mitomycin C to cytoreductive surgery in locally advanced colo-rectal cancer. It will be measured by the incidence rate of adverse events and deaths.
HIPEC technique operating time	36 months after surgery	Average operating time calculation.
HIPEC technique length of hospital stay	36 months after surgery	Average length of hospital stay calculation.
Overall survival	12 months and 36 months after surgery	Evaluate the effect of the addition of HIPEC with Mitomycin C to cytoreductive surgery in 12 months and 3 years overall survival rate (%OS).
HIPEC technique laparoscopic vs laparotomy approach	36 months after surgery	With this outcome it will be calculated the frequency of both surgery techniques and if it has any impact on the locoregional control of the disease.
HIPEC technique open vs. closed HIPEC technique	36 months after surgery	With this outcome it will be calculated the frequency of both surgery techniques and if it has any impact on the locoregional control of the disease.
Quality of life questionnaire QLQ-C30	At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery	With this outcome it will be calculated the effect on the quality of life of patients using questionnaire QLQ-C30.
Quality of life questionnaires QLQ-CR29	At baseline, 1 month after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery and 36 months after surgery	With this outcome it will be calculated the effect on the quality of life of patients using questionnaire QLQ-CR29.
HIPEC technique re-admission rate	36 months after surgery	Average re-admission rate calculation.

Countries

Spain

Outcome results

None listed