Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer (Side)

Sichuan Provincial People's Hospital

Status and phase: Unknown; Phase 2

Conditions: Squamous Cell Carcinoma of Cervix

Treatments: Radiation: Simultaneous boost along with chemo

Study type: Interventional

Funder types: Other

Identifiers

NCT02879214

201604

Details and patient eligibility

About

The purpose of this study is to determine the feasibility of minimal invasive surgical resection through simultaneously integrated dose escalation given concurrently with chemotherapy for locally advanced squamous cell cervical cancer.

Full description

Concurrent radiation therapy and chemotherapy is the standard of care for locally advanced cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into minimal invasive surgical resection after maximal downstage. This protocol is designed to determine the dose escalation of both chemo and radiation for treating tumor bearing regions within the abdomen and pelvis, using an two drug chemotherapy in first cycle of mitomycin/cisplatin or taxol/cisplatin along with simultaneously integrated boost technique to Biological target area defined by PET scan. This dose escalation is to downstage disease for minimal invasive surgical resection.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy confirmed squamous cell carcinoma of cervix, able to receive chemotherapy and concurrent chemoradiotherapy.

Good performance status. Negative pregnancy test in women of child-bearing potential. Signed study-specific informed consent. Lab results within study specific limits

Exclusion criteria

• Prior radiation to the abdomen or pelvis. A history of Scleroderma or Inflammatory bowel disease. Contraindication to chemotherapy or radiation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

SIDE cervical trial

Experimental group

Description:

To Maximal downstage locally advanced squamous cell cervical cancer before minimal invasive surgical resection. The SIDE study is to use both RT dose escalation to the biological target defined by PET and Chemo dose escalation composited with two drugs to achieve maximal reduction of tumor burden, providing feasibility of minimal invasive surgical resection.

Treatment:

Radiation: Simultaneous boost along with chemo