Comparing the side effects between a usual five-week course of radiotherapy versus a more precisely targeted four week course of radiotherapy in patients with cancer of the cervix.

A phase II multi-center, open-label, randomized, parallel-group, superiority study to compare the acute toxicity of Hypofractionated dOse Painted External radiotherapy versus conventional external radiotherapy in patients with carcinoma cervix stage I - IIB. (HOPE) - HOPE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/111292

Enrollment

300

Registered

2026-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: C531- Malignant neoplasm of exocervix

Interventions

Intervention1: Experimental Arm: External beam radiation therapy with volumetric modulated arc therapy to a dose of 42.5 Gy in 20 fractions over 4 weeks to the primary clinical target volume comprisin

Eligibility

Inclusion criteria

Inclusion criteria: Performance stage ECOG 0 to 2 FIGO 2018 Stage I - IIB Squamous cell carcinoma Human papilloma virus positive disease as evaluated using p16 Immunohistochemistry Absence of concomitant comorbidities which prevent administration of concurrent chemotherapy

Exclusion criteria

Exclusion criteria: Non-squamous histology including adenocarcinoma or adenosquamous carcinoma Absence of p16 positive disease Extensive intratuterine involvement or presence of gross pyometra

Design outcomes

Primary

Measure	Time frame
Proportion of grade 2 or higher gastrointestinal toxicity diarrhea, vomiting and nausea defined using CTCAE 6.0.Timepoint: 3 months	—

Secondary

Measure	Time frame
Disease free survivalTimepoint: 3 years;Quality of LifeTimepoint: 6, 12 and 18 months;Late ToxicityTimepoint: 3 years	—

Countries

India

Contacts

Public ContactSantam Chakraborty

Tata Medical Center

drsantam@gmail.com03366057402

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026