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DEPICT: A Phase I/II, Multi-Center Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer


Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

DEPICT: A Phase I/II, Multi-Center Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer


OBJECTIVES:

Primary

- To determine the feasibility of dose-escalation of chemoradiotherapy comprising
cisplatin in combination with simultaneous-boost intensity-modulated radiotherapy
(IMRT) in patients with locally advanced cervical cancer.

Secondary

- To assess the objective response rates in patients treated with this regimen.

- To assess the local control of the disease in patients treated with this regimen.

- To correlate toxicity with dose-volume histogram data in these patients.

OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study.

Patients receive cisplatin IV over 1 hour weekly for up to 5 weeks. Patients also undergo
intensity-modulated radiotherapy 5 days a week for approximately 6 weeks.

Patients complete a quality-of-life questionnaire at baseline, during, and after completion
of study therapy.

After completion of study treatment, patients are followed up at 4 and 12 weeks, every 3
months for 2 years, and then periodically for 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma, adenocarcinoma, or poorly
differentiated carcinoma of the cervix

- Locally advanced disease

- FIGO stage IIB-IVA (any pelvic nodal status) or FIGO stage IB2 and IIA
(with pelvic nodal involvement)

- Measurable disease on MRI scan

- No evidence of common iliac or para-aortic nodal involvement

- No distant metastases

PATIENT CHARACTERISTICS:

- WHO performance status 0-1

- Platelet count > 100 x 10^9/L

- White cell count > 3.0 x 10^9/L

- Neutrophil count > 1.5 x 10^9/L

- ALT/AST < 2.5 times upper limit of normal (ULN)

- Bilirubin < 1.25 times ULN

- EDTA clearance > 55 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior cancer except skin tumor

- No prior pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease,
or diabetes mellitus

PRIOR CONCURRENT THERAPY:

- No prior pelvic radiotherapy or surgery other than laparoscopic node dissection

- No other concurrent anticancer or investigational therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v 3.0

Safety Issue:

Yes

Principal Investigator

Melanie Powell

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Bartholomew's Hospital

Authority:

Unspecified

Study ID:

CDR0000687340

NCT ID:

NCT01230996

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • stage IIB cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • Uterine Cervical Neoplasms

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