A comparative study to assess usefulness of shorter treatment (Simultaneous integrated boost radiotherapy) versus Longer treatment (Sequential boost radiotherapy) in anal canal cancer

Tolerance and efficacy of Sequential boost Versus Simultaneous integrated boost Arc therapy in radical chemoradiotherapy for Carcinoma of Anal canal, Phase III Prospective randomized study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088826

Enrollment

154

Registered

2025-06-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: C218- Malignant neoplasm of overlappingsites of rectum, anus and anal canal

Interventions

Intervention1: Nil: Nil Intervention2: sequential boost radiotherapy: Regular 45Gy in 25 fractions followed by 9Gy in 5 fractions or 14.4 Gy in 9 fractions radiotherapy to the gross disease and electi

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age more than 18 years 2.ECOG PS 0 or 2 3.Histologically proven squamous cell carcinoma of Anal canal 4.Patient undergoing treatment in curative intent concurrent chemoradiotherapy 5.Patients with disease cT2-T4 and/or N0-N1(AJCC 8th) 6.Subjects must have normal organ and marrow function as defined below A.Hematologic Absolute neutrophil count (ANC) Greater than or equal to 1500 per cc platelet count Greater than or equal to 100000 per cc and hemoglobin Greater than or equal to 9 g per dL (may have been transfused) B. Normal Kidney function test and Liver function test

Exclusion criteria

Exclusion criteria: 1.Patient having any other cancer along with Ca anal canal. (now or earlier) 2.Not willing to give consent 3.Unable to complete full treatment. 4.Patients with diagnosed complications of preexisting co-morbidities for which full treatment with concurrent chemoradiotherapy is not feasible. 5.Patients in whom SIB Rapid arc treatment would not be possible due to disease factors (extensive Bilateral bulky nodes) 6.Patients who are HIV positive.

Design outcomes

Primary

Measure	Time frame
1.To assess the incidence of Acute skin Toxicity in simultaneous integrated boost as per CTCAE V5.0. Acute skin toxicity will be defined as the maximum grade of skin toxicity as per CTCAE V5.0 from the start of Radiotherapy to up to 3 months from completion of planned radiotherapy.Timepoint: 2 year	—

Secondary

Measure	Time frame
1.To assess the 2-year Disease Free Survival (DFS) Defined as Recurrence of disease at local or distant site or death from the date of diagnosis 2.To assess the 2-year Overall Survival (OS) Defined as death from any cause calculated from the date of diagnosis 3.Median duration of unplanned Treatment breaks (Due to toxicity) 4.To assess other Acute Toxicity (GI, GU, Haematological, Any other relevant) 5.To assess the late toxicity CTCAE V5.0 6.To assess the Quality of life (EORTC QLQ) Timepoint: 2 YEAR	—

Measure

Time frame

1.To assess the 2-year Disease Free Survival (DFS) Defined as Recurrence of disease at local or distant site or death from the date of diagnosis 2.To assess the 2-year Overall Survival (OS) Defined as death from any cause calculated from the date of diagnosis 3.Median duration of unplanned Treatment breaks (Due to toxicity) 4.To assess other Acute Toxicity (GI, GU, Haematological, Any other relevant) 5.To assess the late toxicity CTCAE V5.0 6.To assess the Quality of life (EORTC QLQ) Timepoint: 2 YEAR

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Countries

India

Contacts

Public ContactDr Lincoln Pujari

Mahamana Pandit Madan Mohan Malviya Cancer Centre

drlincoln.pujari@gmail.com773561666

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026